BETHKIS

Product NDC: 10122-820
11-digit product format: 101220820
Labeler code: 10122
Product ID: 10122-820_32442297-00c4-4800-b7c4-1e2e290f3162
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tobramycin
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Chiesi USA, Inc.
Application: NDA201820
Marketing category: NDA
Marketing start: 2013-04-15
Substance: TOBRAMYCIN
Active strength: 300 mg/4mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201820-001	BETHKIS	TOBRAMYCIN	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N201820-001	AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION		RLD, RS	2012-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION		RLD, RS	2012-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION		RLD, RS	2012-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201820-001	BETHKIS	300MG/4ML	SOLUTION / INHALATION	AN	RLD, RS	2012-10-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N201820-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201820-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201820-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201820-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201820-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201820-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201820-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201820-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201820-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201820-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201820-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201820-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201820-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201820-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201820-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201820-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201820-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201820-001	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N201820-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201820-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201820-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201820-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201820-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201820-001	AN	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	N201820-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201820-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201820-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201820-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201820-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201820-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201820-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201820-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201820-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201820-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201820-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201820-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201820-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201820-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N201820-001	AN	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201820-001	6987094	2022-09-22		Drug product	2013-01-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201820-001	7696178	2022-09-22		Drug product	2013-01-30	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N201820-001	7939502	2022-06-14	U-1324		2013-01-30	`3bdfa0b2c4d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: BETHKIS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	300 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZ8RRZ51VK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1314763	Internal RxNorm lookup
1314768	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1cd3d47b-025f-4705-9daf-cf07725ec223	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9cfa145f-dbe9-bc02-83c2-692786ef6676	Product name	9	20210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796	Product name	4	20210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277	Product name	4	20210625
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10122-820-04	BETHKIS	4 in 1 POUCH	SOLUTION	4	18
10122-820-04	BETHKIS	4 mL in 1 AMPULE	SOLUTION	4	18
10122-820-28	BETHKIS	4 in 1 POUCH	SOLUTION	4	18
10122-820-28	BETHKIS	7 in 1 CARTON	SOLUTION	7	18
10122-820-56	BETHKIS	4 in 1 POUCH	SOLUTION	4	18
10122-820-56	BETHKIS	14 in 1 CARTON	SOLUTION	14	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10122-820-04	ML - Milliliter	10122-820	82f319d6-24a6-4066-8730-cc94c62d9cc8	1	2013-10-17
10122-820-28	ML - Milliliter	10122-820	b53c2773-8ae8-4bb0-b6eb-01c786602cb8	1	2014-06-03
10122-820-56	ML - Milliliter	10122-820	32f0afe2-1cd8-4c9e-a73e-1932b8457fcc	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10122-820	BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]	18	Current NDC, Legacy NDC, 6 package rows	20230223_1cd3d47b-025f-4705-9daf-cf07725ec223.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BETHKIS	TOBRAMYCIN	Chiesi USA, Inc.	1cd3d47b-025f-4705-9daf-cf07725ec223	2023-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201820 application number: NDA201820 ndc (product): 10122-820
Tobramycin Inhalation	TOBRAMYCIN INHALATION	Prasco, LLC	b5b51665-c427-42b9-bd6e-6e3c06f650e1	2023-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201820 application number: NDA201820

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1314768	Bethkis 300 MG in 4 ML Inhalation Solution	PSN	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314763	tobramycin 300 MG in 4 ML Inhalation Solution	PSN	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314768	tobramycin 75 MG/ML Inhalation Solution [Bethkis]	SBD	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314763	tobramycin 75 MG/ML Inhalation Solution	SCD	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314768	Bethkis 300 MG per 4 ML Inhalation Solution	SY	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314768	Bethkis 75 MG/ML Inhalation Solution	SY	1cd3d47b-025f-4705-9daf-cf07725ec223	18
1314763	tobramycin 300 MG per 4 ML Inhalation Solution	SY	1cd3d47b-025f-4705-9daf-cf07725ec223	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10122-820-04	10122082004	4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE	4 ampule	2013-04-15		No	No	Current
10122-820-28	10122082028	7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE	7 pouch	2013-04-15	0000-00-00	No	No	Current
10122-820-56	10122082056	14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE	14 pouch	2013-04-15	0000-00-00	No	No	Current